According to Dr. Mark Wurster, M.D.:
The problem with dabigatran is that it has been presented as a "fire-and-forget" medicine. That is, the doctor can write a prescription and not think about it again. But anticoagulation is not like that. Just because patients on dabigatran don't need to have regular INR measurements doesn't mean they don't need monitoring.
Dr. Wurster made this statement after he presented preliminary results from his study “Dabigatran in the Real World” at the Thrombosis & Hemostasis Summit of North America (THSNA) in Chicago this month. This study, done over the course of more than a year, followed each of 113 patients for six months after each had been switched from warfarin to Pradaxa.
According to Dr. Wurster, there were 13 total incidents of serious adverse reactions to Pradaxa, including a death resulting from a Pradaxa-related bleeding incident, as compared to a single incident of warfarin toxicity resulting from warfarin treatment.
While Dr. Wurster is reluctant to call Pradaxa a “bad drug”, he has concerns regarding appropriate patient selection and regarding monitoring of those who use Pradaxa. His results indicate that Pradaxa’s adverse effects appear more frequently in elderly populations and in female populations. The mean age for adverse event suffers was 73.4, and 71% of adverse event suffers were female.
He adds that the price of Pradaxa exacerbates this problem. "Many patients will start cutting the tablets in half or stop taking them altogether because of the expense. And that will be a big problem. If a patient was not compliant on warfarin, they will fare worse on these new drugs."
This study is only one item in a string of bad news reports for Boehringer Ingelheim since Pradaxa hit the market in late 2010. Last month, Pradaxa earned a spot on the Top Ten Drugs with the Most Adverse Reports List for 2011, and lawsuits from serious and fatal bleeding events continue to mount.